Quality Compliance Specialist Change Control

Company Name:
Regeneron is currently seeking a talented and motivated Quality Compliance Specialist to join our QA department reporting to the Associate Director of Quality Systems. The position responsibilities include day-to-day quality assurance review and approval of change proposals, facilitating cross functional meetings, providing guidance and consultation to change proposal owners, and working collaboratively with partners and CMOs to ensure changes are communicated and implemented in accordance with quality agreements and standard operating procedures. This position requires prior QA experience in working Biotech/pharmaceutical industry and proven success operating in a change control quality system.
Essential Functions:
Perform QA review and approval of change proposals to ensure compliance with written SOPs
Provide general assistance to change owners and approvers
Generate weekly/monthly metrics and trend reports for the Change Control system.
Contribute to continuous improvement and development of the change control program
Interprets compliance requirements for incorporation into company systems/procedures.
Becomes involved as required to meet schedules or resolve problems at peer level.
Support regulatory and customer audits.
Additional responsibilities assigned by manager which may include assistance with process transfers, partner communications, maintenance of quality agreements, etc.
Experience and Required Skills:
Required Skills:
Knowledge of quality systems utilized in biotech/pharmaceutical specifically change control
Strong interpersonal, written and oral communication skills
Knowledge of Pharmaceutical Quality Assurance, regulatory compliance or quality control inclusive of cGMP, FDA regulations, familiarity with ICH guidelines and EU regulations.
Knowledge of MS word, Excel, database management and statistical analysis
Ability to effectively organize and manage work responsibilities of self independently.
Ability to understand complex interrelationships
Education and Experience:
Requires BS/BA in scientific or engineering discipline or related field with 2-5 years of related work experience in pharmaceutical or related industry. Previous QA experience in change control quality system required.
Certified Quality Engineer (a plus).

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